EndoFLIP® System With FLIP Topography Module
System, Gastrointestinal Motility (electrical)
Crospon Ltd.
The following data is part of a premarket notification filed by Crospon Ltd. with the FDA for Endoflip® System With Flip Topography Module.
Pre-market Notification Details
| Device ID | K170833 |
| 510k Number | K170833 |
| Device Name: | EndoFLIP® System With FLIP Topography Module |
| Classification | System, Gastrointestinal Motility (electrical) |
| Applicant | Crospon Ltd. Galway Business Park, Dangan Galway, IE |
| Contact | John O’dea |
| Correspondent | Paul Dryden Crospon Ltd., C/oProMedic, LLC 24301 Woodsage Dr. Bonita Springs, FL 34135 |
| Product Code | FFX |
| CFR Regulation Number | 876.1725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-20 |
| Decision Date | 2017-04-17 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05391530810142 | K170833 | 000 |
Trademark Results [EndoFLIP]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ENDOFLIP 77172827 4116590 Live/Registered |
FLIP TECHNOLOGIES LIMITED 2007-05-04 |
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